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Zoster (shingles)

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Zoster (shingles)

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Zoster (shingles)
 
Zoster (shingles)
Disease Issues Contraindications and Precautions
Vaccine Recommendations Administering Vaccines
Immunocompromised Adults Storage and Handling
Vaccine Safety  
Disease Issues
What is the cause of herpes zoster (shingles)?
Herpes zoster is a painful rash that occurs along one or more dermatomes. Zoster is caused by reactivation of latent varicella zoster virus infection from a prior chickenpox infection. People who have had a prior infection with varicella zoster virus (chickenpox) are at risk of shingles.
How common is herpes zoster (shingles)?
During their lifetime about 30% of Americans will develop herpes zoster, which translates into an estimated 1 million cases each year in this country. The risk of zoster increases with increasing age; about half of all cases occur among people age 60 years or older. People who are immunosuppressed, including those with leukemia, lymphoma, and human immunodeficiency virus (HIV) infection, and people who receive immunosuppressive drugs, such as steroids and cancer chemotherapy, also are at greater risk of zoster. Most people have only one episode of shingles. The risk of recurrence is low in people who are not immunosuppressed, but the precise incidence is unknown.
Can you catch zoster from a person with active zoster infection?
Zoster is caused by reactivation of a latent varicella virus infection (from having chickenpox in the past). Zoster is not passed from one person to another through exposure to another person with zoster. However, if a person who is susceptible to chickenpox (i.e., they had never had chickenpox and were not vaccinated against chickenpox) comes in direct contact with a person with a zoster rash, the virus could be transmitted to the susceptible person. The exposed person would develop chickenpox, not zoster. Covering the zoster rash reduces the chances of transmitting varicella zoster virus.
For our "Mother's Day Out" program, one of the teachers has shingles. The program serves moms of 2-month-olds to 4-year-olds. All children are up to date with their vaccinations, but some are too young to have received varicella vaccine. Is it safe for the teacher to work?
In a school setting, an immunocompetent person with zoster (staff or students) can remain at school as long as the lesions can be completely covered. People with zoster should be careful about personal hygiene, wash their hands after touching their lesions, and avoid close contact with others. If the lesions cannot be completely covered and close contact avoided, the person should be excluded from the school setting until the zoster lesions have crusted over. See www.cdc.gov/chickenpox/outbreaks/manual.html for more information. If your program is licensed by a state or county, you should check their regulations as well.
Should healthcare personnel in long-term care facilities be tested to see if they have had chickenpox before taking care of someone who has shingles?
All healthcare personnel should ensure they are immune to varicella regardless of the setting in which they work. For healthcare personnel, accepted evidence of varicella immunity includes any of the following: 1) documentation of age-appropriate vaccination with a varicella vaccine, 2) laboratory evidence of immunity or laboratory confirmation of disease; 3) diagnosis or verification of a history of varicella disease by a healthcare provider; or 4) diagnosis or verification of a history of herpes zoster by a healthcare provider.
Vaccine Recommendations Back to top
What zoster vaccine is available in the United States?
Recombinant zoster vaccine (RZV, Shingrix, GlaxoSmithKline) was licensed by the Food and Drug Administration (FDA) in October 2017. It is a subunit vaccine that contains recombinant varicella zoster virus (VZV) glycoprotein E in combination with a novel adjuvant (AS01B). Shingrix does not contain live VZV. It is FDA-approved and recommended by the Advisory Committee on Immunization Practices (ACIP) for all people 50 years and older and for adults age 19 years or older who are or will be immunodeficient or immunosuppressed because of disease or therapy. It has not been evaluated and is not approved for the prevention of primary varicella infection. Shingrix is administered as a 2-dose series by the intramuscular route. The second dose should be given 2 to 6 months after the first dose, with a minimum interval of 1 month (4 weeks) between doses.
Zoster vaccine live (ZVL, Zostavax, Merck) is a live attenuated vaccine that was licensed by the FDA in 2006 for adults age 50 and older and recommended by ACIP for people age 60 and older. Zostavax has been unavailable for use in the United States since November 18, 2020.
How effective is Shingrix?
Shingrix was studied in immunocompetent adults in 2 pre-licensure clinical trials. Efficacy against shingles was 97% for people 5059 years of age, 97% for people 6069 years of age, and 91% for people 70 years and older. Among people 70 years and older vaccine efficacy was 85% four years after vaccination.
Vaccine effectiveness (VE) has been evaluated for a limited number of specific immunocompromising conditions. VE estimates vary depending upon the underlying cause of immunocompromise. Studies have estimated VE of 68.2% for autologous hematopoietic cell transplant recipients, and 87.2% and 90.5% for patients with hematologic malignancies and potential immune-mediated diseases, respectively.
Will administering zoster vaccine reduce the risk of postherpetic neuralgia (PHN) if a vaccinated person develops shingles?
Yes. In clinical trials among immunocompetent adults age 50 years or older, Shingrix reduced the risk of PHN by 91%. One study among hematopoietic cell transplant recipients reported that vaccination reduced the risk of PHN by 89%.
To whom should zoster vaccine be given?
Shingrix is recommended for the prevention of herpes zoster and related complications for immunocompetent adults 50 years of age and older, including those who previously received Zostavax. On October 20, 2021, ACIP recommended 2 doses of RZV for the prevention of herpes zoster and related complications in adults age 19 years or older who are or will be immunodeficient or immunosuppressed because of disease or therapy.
ACIP published its zoster vaccination recommendations for immunocompetent adults age 50 years and older in January 2018: www.cdc.gov/mmwr/volumes/67/wr/pdfs/mm6703a5-H.pdf.
ACIP published its recommendations for the use of recombinant zoster vaccine in adults age 19 years or older who are or will be immunocompromised in January 2022: www.cdc.gov/mmwr/volumes/71/wr/pdfs/mm7103a2-H.pdf.
My clinic cannot consistently keep Shingrix in stock due to high demand. How should we handle challenges ensuring patients receive a second dose?
Clinicians and patients should make every effort to ensure that two doses of Shingrix are administered within the recommended interval of 2 to 6 months. If more than 6 months have elapsed since the first dose of Shingrix, administer the second dose when possible. Do not restart the vaccine series.
Additional information for clinicians about Shingrix is available on the CDC website at www.cdc.gov/vaccines/vpd/shingles/hcp/index.html.
Should Shingrix be given to people who have already received Zostavax? If so, what interval should separate them?
Yes. ACIP recommends that people who previously received Zostavax receive 2 doses of Shingrix. The first dose of Shingrix may be given a minimum of 8 weeks after Zostavax.
What is the minimum interval between doses of Shingrix?
The recommended interval between Shingrix doses is 2 to 6 months. The minimum interval between doses of Shingrix is 4 weeks. If the second RZV dose is given more than 4 days sooner than 4 weeks after the first dose, a valid second dose should be repeated at least 4 weeks after the dose given too early.
For adults who are or will be immunodeficient or immunosuppressed and who would benefit from a shorter vaccination schedule, the second dose can be administered 12 months (a minimum of 4 weeks) after the first dose.
What is the minimum age for administering Shingrix?
The routinely recommended minimum age for Shingrix among immunocompetent adults is 50 years. However, if a dose is inadvertently administered to an immunocompetent adult 18 through 49 years of age CDC does not recommend repeating the dose. The second Shingrix dose should not be administered until the 50th birthday. This guidance does not appear in the most recent zoster ACIP statement but is in the General Best Practices Guidance (Table 3-1 in the Timing and Spacing of Immunobiologics section at www.cdc.gov/vaccines/hcp/acip-recs/general-recs/timing.html) and is based on guidance from CDC's zoster subject matter experts.
Among people who are or will be immunosuppressed or immunodeficient due to disease or therapy, the minimum age for vaccination is 19 years.
If the second dose of Shingrix is delayed more than 6 months after the first dose do I need to restart the series?
No. The vaccine series need not be restarted if more than 6 months have elapsed since the first dose.
Is there an upper age limit for receipt of zoster vaccine?
No.
If a patient received dose 1 of varicella vaccine (Varivax or ProQuad, Merck) at age 60 years, should we administer zoster vaccine as dose 2?
The action taken depends on why varicella vaccine was given in the first place. If it was given because the person tested negative for varicella antibody, then the next dose should be varicella vaccine. If the varicella vaccine was given in error (i.e., without serologic testing), then Shingrix should be given.
Should a person who received 2 doses of varicella vaccine but never had chickenpox be vaccinated with Shingrix?
Shingrix may be administered to people who have previously received 2 doses of varicella vaccine. Compared to people who have had chickenpox, the risk of zoster among recipients of varicella vaccine (which contains a live-attenuated strain of varicella virus) is much lower, but is still possible.
Before administering Shingrix is it necessary to ask if the person has ever had chickenpox or shingles?
All immunocompetent people age 50 years or older-whether they have a history of chickenpox or shingles or not-should be given Shingrix unless they have a medical contraindication to vaccination. Among this population it is not necessary to ask about a history of chickenpox or to test for varicella antibody prior to or after giving the vaccine.
Among immunocompromised people age 19 years or older, evidence of a history of varicella illness or varicella vaccination (confirming the need for Shingrix as a result of a history of exposure to a live varicella virus, whether the wild or live-attenuated vaccine strain) IS recommended. Shingrix may be administered to an immunocompromised person who has had chickenpox or shingles or has previously been vaccinated with varicella vaccine or zoster vaccine live. See the Immunocompromised Adults section below for additional information about partially-vaccinated immunocompromised adults with no history of chickenpox.
Should people who haven't had chickenpox or any doses of varicella-containing vaccine be vaccinated with recombinant zoster vaccine (Shingrix)?
A person who has never been exposed to varicella virus through infection or vaccination with varicella vaccine or zoster vaccine live is not at risk for shingles. Shingrix has not been evaluated for the prevention of primary infection with varicella virus. People who have never had chickenpox are recommended to receive 2 doses of varicella vaccine.
Serologic studies indicate that about 99% of people born before 1980 worldwide have had chickenpox even though many cannot recall having had chickenpox (www.cdc.gov/mmwr/preview/mmwrhtml/rr5705a1.htm). As a result, there is no need to ask immunocompetent people age 50 years and older for their varicella disease history or to perform a laboratory test for serologic evidence of prior varicella disease.
Immunocompromised adults age 19 years and older without evidence of exposure to live varicella virus through a history of chickenpox, zoster, or documentation of vaccination with live varicella vaccine (Varivax or ProQuad, Merck) or zoster vaccine live (Zostavax, Merck) should be evaluated further. Birth before 1980 is not sufficient proof of immunity for immunocompromised adults. For immunocompromised adults, evidence of immunity to varicella (confirming need for RZV) includes:
  • Documentation of two doses of varicella vaccine, or
  • Laboratory evidence of immunity or laboratory confirmation of disease, or
  • Diagnosis or verification of a history of varicella or herpes zoster by a healthcare provider.
For any adult who is clinically determined to be susceptible to primary varicella infection, refer to the ACIP varicella vaccine recommendations for further guidance, including post-exposure prophylaxis guidance for immunocompromised adults: www.cdc.gov/mmwr/preview/mmwrhtml/rr5604a1.htm.
CDC has published clinical considerations for shingles vaccination of immunocompromised patients who lack evidence of immunity to chickenpox: www.cdc.gov/shingles/vaccination/immunocompromised-adults.html#special-populations.
Can someone who has experienced an episode of shingles be vaccinated with zoster vaccine?
Yes. Adults with a history of herpes zoster should receive Shingrix. If a person is experiencing an episode of zoster, vaccination should be delayed until the acute phase of the illness is over and symptoms abate.
If a person was exposed to shingles by a spouse within the last few days, is there a recommended waiting period before the exposed person can receive zoster vaccine?
There is no waiting period in such a situation. Shingles is not caused by exposure to another person with shingles. Shingles is caused by the reactivation of varicella zoster virus (VZV) in people who have had a prior VZV infection or varicella vaccination. However, exposure to someone with shingles can possibly cause chickenpox in a person with no immunity to varicella zoster virus (VZV) from either vaccination or prior chickenpox infection.
A 33-year-old patient in my practice has already suffered from three episodes of shingles. He would like to receive Shingrix. Is this a good idea?
ACIP recommends vaccination with Shingrix for adults age 19 years or older who are immunodeficient or immunosuppressed due to disease or therapy. Repeated shingles episodes are often associated with immunocompromise. If your patient's recurrent shingles episodes are evaluated and clinically concluded to be the result of immunodeficiency or immunosuppression, he should be vaccinated with a two-dose series of Shingrix.
We have a healthy 20-year-old patient who had a history of chickenpox disease. They now have shingles even though they have no known immunocompromising condition. Should we administer Shingrix after they recover?
The Advisory Committee on Immunization Practice (ACIP) does not recommend zoster vaccination for immunocompetent people younger than age 50 years regardless of their history of shingles.
Can zoster vaccine be administered to people in long-term care facilities?
Yes, unless they have a contraindication to vaccination.
Can I give our long-term care residents zoster vaccine, injectable influenza, and pneumococcal vaccines on the same day?
Yes. CDC's General Best Practice Guidelines for Immunization advise that non-live vaccines, such as Shingrix, can be administered concomitantly, at different anatomic sites, with any other live or non-live vaccine, including the vaccines you listed, as well as COVID-19 vaccines. They should be given as separate injections, not combined in the same syringe.
Is documented receipt of Shingrix, in the absence of other criteria, proof of immunity to varicella?
No. Documented receipt of Shingrix cannot be used as proof of immunity to varicella. Additionally, a dose of Shingrix cannot be counted as a dose of varicella vaccine.
Can I give Shingrix at the same time as a tuberculin skin test?
Yes. Shingrix is not a live virus vaccine and does not interfere with the tuberculin skin test (TST): it may be administered any time before or after a TST. Administration of a live virus vaccine can interfere with a tuberculin skin test (TST). If the TST is not administered on the same day as a live virus vaccine, the TST should be delayed until 46 weeks after the vaccination.
Immunocompromised Adults Back to top
Where can I find CDC's guidance for vaccination of immunocompromised adults?
ACIP published its recommendations for the use of recombinant zoster vaccine in adults age 19 years or older who are or will be immunocompromised in January 2022, available at www.cdc.gov/mmwr/volumes/71/wr/pdfs/mm7103a2-H.pdf.
These recommendations should be implemented in conjunction with CDC's Clinical Considerations for the Use of Recombinant Zoster Vaccine (RZV, Shingrix) in Immunocompromised Adults Aged >19 Years: www.cdc.gov/shingles/vaccination/immunocompromised-adults.html.
Is Shingrix effective for immunocompromised adults?
Shingrix has been studied in people with certain types of immunocompromise and has been shown to have moderate to high effectiveness against herpes zoster and postherpetic neuralgia. Because the causes of immunocompromise are so varied, the effectiveness and durability of protection provided by Shingrix also may vary depending upon the precise nature and severity of immunocompromise in a given individual.
Is Shingrix safe for immunocompromised adults?
ACIP and the FDA have determined that Shingrix is acceptably safe in immunocompromised individuals. Immune-mediated diseases were evaluated in six studies in five immunocompromised groups and were not increased among RZV recipients. One study in patients with hematologic cancers reported on graft-versus-host-disease among hematopoietic cell transplant recipients and did not identify an increased risk among RZV recipients. One study among kidney transplant patients reported on graft rejection and did not identify an increased risk among RZV recipients. Local and systemic grade 3 reactions (reactions that interfere with daily activities) were evaluated in six studies in five immunocompromised groups. Local grade 3 reactions occurred in 10.7% to 14.2% of RZV recipients, and systemic grade 3 reactions occurred in 9.9% to 22.3% of RZV recipients. Systemic grade 3 reactions were also reported by 6.0% to 15.5% of placebo recipients in these studies.
What is the best time to vaccinate a patient who requires immunosuppression?
Timing of vaccination should be evaluated on a case-by-case basis. When possible, patients should be vaccinated before becoming immunosuppressed. If vaccination before initiating immunosuppressive treatment is feasible, a shortened interval of 4 weeks between doses 1 and 2 may be considered. If vaccination before immunosuppression is not possible, providers should consider timing vaccination when the immune response is likely to be most robust.
For additional information about timing of vaccination and specific conditions, see CDC's Clinical Considerations for the Use of Recombinant Zoster Vaccines in Immunocompromised Adults Aged ≥19 Years: www.cdc.gov/shingles/vaccination/immunocompromised-adults.html#clinical-guidance.
Why do I need to consider evidence of immunity before vaccinating an immunocompromised person with Shingrix? Won't Shingrix protect them from chickenpox?
People who have neither experienced primary varicella infection (chickenpox), nor received live-attenuated varicella vaccine (vaccine strain VZV, contained in Varivax, ProQuad, and Zostavax, all by Merck) are not at risk for shingles. More than 99% of Americans born before 1980 have had chickenpox, even if they don't remember it, so additional screening is not recommended for immunocompetent people born before 1980 who are due for routine shingles vaccination. Children and adolescents who have received live-attenuated varicella vaccines (Varivax or ProQuad) are at risk for shingles, although they are at lower risk for shingles than are those who experienced chickenpox.
Shingrix (RZV) is not indicated and has not been studied for the prevention of chickenpox. Receipt of Shingrix is not considered proof of varicella immunity, and Shingrix cannot be considered as either of the two doses of the varicella vaccine series. In addition, there are limited data on the use of Shingrix in people without a history of chickenpox, with or without a history of varicella vaccination.
The consequences of primary varicella infection in immunocompromised adults can be severe. For adults who are or will be immunocompromised, evidence of immunity to varicella (confirming need for RZV) includes:
  • Documentation of two doses of varicella vaccine, or
  • Laboratory evidence of immunity or laboratory confirmation of disease, or
  • Diagnosis or verification of a history of varicella or herpes zoster by a healthcare provider.
Protection from primary varicella infection (chickenpox) is a priority for an adult who is or will be immunocompromised with no evidence of immunity to chickenpox. Refer to the ACIP varicella vaccine recommendations for further guidance, including post-exposure prophylaxis guidance for immunocompromised adults: www.cdc.gov/mmwr/preview/mmwrhtml/rr5604a1.htm.
Should an immunocompromised adult who has no history of chickenpox but who received only one dose of live-attenuated varicella vaccine receive Shingrix?
An adult who has documentation of one dose of varicella vaccine is potentially at risk for chickenpox (from exposure to a person with chickenpox) AND herpes zoster (either from a possible previous unrecognized case of chickenpox or from the vaccine strain of the virus).
CDC subject matter experts advise that clinical management of a person with no proof of a past primary varicella infection and a history of only one varicella vaccination who is or will be immunocompromised depends upon the degree of immunocompromise of the patient:
  • If varicella vaccine is not already contraindicated due to significant immunocompromise, give the second varicella vaccine dose. Depending on the patient's immunocompromising condition or therapy, the clinician may then consider initiating the Shingrix series at least 8 weeks after the second varicella vaccine dose to reduce the risk of herpes zoster.
  • If the patient already has significant immunocompromise and the second varicella vaccine dose is contraindicated, the clinician should:
    • Consider the patient's herpes zoster risk (based on their immunocompromising condition or therapy). On a case-by-case basis and if the clinician determines it is indicated, administer the Shingrix series to reduce the risk of herpes zoster.
    • Be prepared to administer varicella immune globulin (VariZIG, Saol Therapeutics) in the event that the patient has a recognized exposure to a person with chickenpox, regardless of whether or not the patient received RZV.
For more information, see www.cdc.gov/shingles/vaccination/immunocompromised-adults.html.
My patient is age 34 years and has well-controlled HIV infection, but no history of varicella vaccination, chickenpox, or shingles. Do I need to have proof of a history of varicella disease or vaccination before I vaccinate with Shingrix?
Immunocompromised adults age 19 years and older without evidence of exposure to live varicella virus through a history of chickenpox, zoster, or documentation of vaccination with live varicella vaccine (Varivax or ProQuad, Merck) or zoster vaccine live (Zostavax, Merck) should be evaluated further for their risk of zoster before receiving Shingrix. Birth before 1980 is not sufficient proof of a history of primary varicella infection (chickenpox) for immunocompromised adults.
Vaccination with varicella vaccine to prevent chickenpox may be considered for a patient with well-controlled HIV (e.g., CD4+ T-lymphocyte percentage of at least 15% and a count of at least 200 cells per microliter) and no evidence of a history of varicella disease or vaccination. Vaccination may be considered for a patient who has a CD4 count of at least 200 cells per microliter but no information on percentage. Vaccination is contraindicated if a patient has laboratory information on the CD4 percentage and/or count and either measure falls below the recommended acceptable threshold for vaccination.
For other situations involving immunocompromised adults with no evidence of a history of varicella disease or vaccination, see detailed guidance provided by CDC at www.cdc.gov/shingles/vaccination/immunocompromised-adults.html#special-populations.
My patient recently underwent a hematopoietic cell transplant (HCT) and his oncology team plans to maintain him on antiviral therapy with valacyclovir for the next 12 months. When should he receive Shingrix?
Valacyclovir, acyclovir, and famciclovir are antiviral medications that are active against herpesviruses, including varicella zoster virus. The risk of shingles risk is reduced during antiviral treatment. Since Shingrix is not a live virus vaccine, Shingrix may be administered while patients are taking antiviral medications if indicated.
A patient who is taking a prophylactic antiviral for a fixed period of time while their immune system recovers from HCT, should ideally initiate vaccination with Shingrix about 2 months prior to discontinuation of antiviral therapy.
Regardless of the duration of antiviral therapy after HCT, CDC recommends that autologous HCT recipients wait at least 3 months after transplant before initiating Shingrix vaccination. Allogenic HCT recipients should wait at least 6 months after transplantation. For additional details on timing after HCT, see www.cdc.gov/shingles/vaccination/immunocompromised-adults.html#clinical-guidance.
I have an oncology patient age 35 years who had chickenpox as a child and is going to be initiating chemotherapy soon. What are the guidelines in such a situation?
The risk for zoster and its severe morbidity and mortality is much greater for immunosuppressed people. A 2-dose series of Shingrix should be administered as soon as possible while the person's immune system is intact. In cases such as this, depending upon the timing of chemotherapy initiation, you may wish to consider a shorter interval of at least 4 weeks (1 month) in order to complete the series as soon as possible.
When can a patient who is immunocompetent now but who was on immunosuppressive chemotherapy in the past receive zoster vaccine?
A person who was on immunosuppressive chemotherapy in the past but is not expected to be immunocompromised again may follow routine recommendations for shingles vaccination at age 50 years or older. If the patient is age 19 or older and expected to require repeated exposure to immunosuppressive chemotherapy in the future, then it is preferable to vaccinate now while the patient's immune system is more robust.
Can someone with hepatitis C receive zoster vaccine?
Hepatitis C infection is not a contraindication for Shingrix vaccination. However, if someone with hepatitis C is receiving a medication that can cause immunosuppression, they should consult with their healthcare provider to discuss the clinical considerations for the timing of vaccination. Detailed guidance is available at www.cdc.gov/shingles/vaccination/immunocompromised-adults.html#clinical-guidance.
Can a person age 60 years or older with a diagnosis of an autoimmune disease, such as lupus or rheumatoid arthritis, receive zoster vaccine?
Yes. Shingrix can be administered in this situation. Optimally, vaccination should occur when the disease is well-controlled and not during an acute disease flare.
My patient takes rituximab. When is the best time to vaccinate him?
For patients receiving anti-B cell therapies (e.g., rituximab), CDC recommends administering a dose of RZV approximately 4 weeks prior to the next scheduled therapy.
I have a 30-year-old patient who has been diagnosed with rheumatoid arthritis and will be starting immunosuppressing medication. She has no documentation of varicella vaccination and she cannot recall having chickenpox. Do I give her Shingrix?
Shingrix has not been evaluated for, and is not recommended for, the prevention of primary infection with varicella virus (chickenpox).
In this case, the patient is not yet immunocompromised and has no evidence of immunity to varicella. The simplest next step is to vaccinate the patient with two doses of varicella vaccine, spaced at least 4 weeks apart, before initiating immunosuppressing medication.
If you wish, you may order a commercial serologic assay to look for evidence of past varicella virus exposure. However, remember that the sensitivity and specificity of these tests vary, and while such commercial tests can detect evidence of past varicella infection, they are not sensitive enough to reliably detect evidence of past vaccination with varicella vaccine.
For patients who lack evidence of past infection or vaccination and who are immunocompromised already, CDC has provided additional detailed clinical considerations here: www.cdc.gov/shingles/vaccination/immunocompromised-adults.html#special-populations.
My patient already has advanced HIV disease, is it too late to vaccinate with RZV?
No. Antiretroviral treatment for HIV may improve immune response to vaccination; however, vaccination for shingles does not have to be delayed in order to achieve viral suppression, especially if this will significantly delay vaccine administration. Patients with advanced HIV should receive RZV, because the risk of shingles is further increased in the setting of such immune compromise.
Vaccine Safety Back to top
What adverse reactions have been reported with Shingrix?
In pre-licensure clinical trials of Shingrix in immunocompetent adults age 50 years or older, the most common adverse reactions were pain at the injection site (78%), myalgia (45%), and fatigue (45%). Any grade 3 adverse event (reactions related to vaccination which were severe enough to prevent normal activities) was reported in 17% of vaccine recipients compared with 3% of placebo recipients. Grade 3 injection-site reactions (pain, redness, and swelling) were reported by 9% of vaccine recipients, compared with 0.3% of placebo recipients. Grade 3 solicited systemic events (myalgia, fatigue, headache, shivering, fever, and gastrointestinal symptoms) were reported by 11% of vaccine recipients and 2.4% of placebo recipients. The occurrence of local grade 3 reactions did not differ by vaccine dose. However systemic grade 3 reactions were reported more frequently after dose 2.
Rates of serious adverse events (an undesirable experience associated with the vaccine that results in death, hospitalization, disability or requires medical or surgical intervention to prevent a serious outcome) were similar in vaccine and placebo groups.
Among immunocompromised recipients of RZV, local grade 3 reactions occurred in 10.7% to 14.2% of RZV recipients, and systemic grade 3 reactions occurred in 9.9% to 22.3% of RZV recipients, compared with 0% to 0.3% and 6.0% to 15.5%, respectively, among placebo recipients. Limited studies have found no evidence of an increased risk of immune-mediated diseases, graft-versus-host-disease, or transplant rejection among certain categories of immunocompromised RZV recipients.
What should I advise my patients about adverse reactions after Shingrix?
Before vaccination, providers should counsel Shingrix recipients about common expected systemic and local adverse reactions (described above). Reactions to the first dose do not strongly predict reactions to the second dose.
If a patient experiences side effects, any local (e.g., redness, pain, swelling at the injection site) or systemic (e.g., fever, chills, headache, body aches) reactions typically go away within 72 hours after vaccination. It is generally not recommended to take medication for pain or fever (e.g., acetaminophen or ibuprofen) before vaccination; however, such medications may be taken to alleviate local or systemic symptoms after vaccination, if needed. Shingrix recipients should be encouraged to complete the series even if they experienced a grade 3 reaction to the first dose.
Can the Shingrix vaccine cause shingles?
No. Shingrix contains only a small part of the varicella zoster virus that causes shingles. Shingrix does not contain any live varicella zoster virus.
Contraindications and Precautions Back to top
What are the contraindications to Shingrix?
The only contraindication is a severe allergic reaction to a vaccine component or following a prior dose.
What are the precautions to the administration of Shingrix?
The only precaution is the presence of a moderate or severe acute illness, including having an active case of herpes zoster. If the patient has zoster, vaccination should be deferred until lesions have crusted and symptoms have abated.
There is currently no ACIP recommendation for RZV use in pregnancy; therefore, providers should consider delaying RZV until after pregnancy. There is no recommendation for pregnancy testing before vaccination.
I have an immunocompromised patient who recently gave birth and is breastfeeding. Do we defer Shingrix until breastfeeding ends?
Breastfeeding is NOT a precaution to vaccination with Shingrix (RZV). Recombinant vaccines such as RZV pose no known risk to mothers who are breastfeeding or to their infants. Clinicians should consider vaccination without regard to breastfeeding status if RZV is otherwise indicated.
If an adult eligible for RZV has already had zoster with postherpetic neuralgia or ophthalmic complications, when can they receive zoster vaccine?
Once they are no longer acutely ill, they can be vaccinated with Shingrix. There is no evidence that vaccine will have therapeutic effect for a person with existing zoster or postherpetic neuralgia.
How long should we wait before giving Shingrix to a patient who has had a blood transfusion?
There is no waiting period for administering Shingrix following transfusion. Shingrix contains no live virus so may be given at any time after receipt of a blood product.
A 65-year-old patient is having major back surgery next week. He is requesting zoster vaccine today. Can I give him the vaccine?
Yes. Shingrix can be administered in this situation.
We have a 61-year-old patient who is taking 500 mg of valacyclovir (Valtrex) daily. Can she receive Shingrix?
Yes. Acyclovir, famciclovir, and valacyclovir are antiviral drugs that are active against herpesviruses. These drugs will have no effect on Shingrix, which does not contain live varicella virus.
If my patient is taking Tamiflu (oseltamivir), can she receive zoster vaccine?
Yes. Although oseltamivir is an antiviral drug, it is only effective against influenza A and B viruses. Shingrix does not contain live virus and will not be affected by oseltamivir.
Administering Vaccines Back to top
How is recombinant zoster vaccine (RZV, Shingrix) administered?
Reconstitute recombinant zoster vaccine (RZV, Shingrix, GSK) using only the adjuvant solution provided with the vaccine antigen. After reconstitution, administer Shingrix immediately by the intramuscular route or store the reconstituted vaccine refrigerated between 2° and 8°C (36° and 46°F) and use within 6 hours. Discard reconstituted vaccine if not used within 6 hours or if frozen. If Shingrix is reconstituted with other than the supplied adjuvant solution, it should be repeated. The dose can be repeated immediately. There is no interval that must be met between these doses.
A patient was inadvertently given Shingrix by the subcutaneous rather than the intramuscular route. Does the dose need to be repeated?
Shingrix has been shown to be immunogenic when given by the subcutaneous route. A dose erroneously given by this route does not need to be repeated.
When reconstituted, the volume of Shingrix is more than 0.5 mL. Should the entire volume of reconstituted vaccine be administered or just 0.5 mL as indicated in the package insert?
The Shingrix adjuvant solution may contain up to 0.75 mL of liquid. The entire volume of the adjuvant solution should be withdrawn and used to reconstitute the lyophilized vaccine. After mixing, withdraw the recommended dose of 0.5 mL. Discard any reconstituted vaccine left in the vial.
Can pharmacists in all states administer zoster vaccine?
According to the American Pharmacist Association, all states allow pharmacists to administer zoster vaccine. Not all pharmacists provide vaccination services, and of those who do, not all administer zoster vaccine. It is best to call the pharmacy ahead of time to find out if they have Shingrix to administer to your patients. The vaccine must be administered in the pharmacy. Do NOT instruct the patient to transport the vaccine from the pharmacy back to your office. This could damage the potency of the vaccine.
A 60-year-old patient was inadvertently given varicella vaccine instead of Shingrix. Should the patient still be given Shingrix? If so, how long an interval should occur between the 2 doses?
CDC recommends that if a provider mistakenly administers varicella vaccine to a person for whom zoster vaccine is indicated, no specific safety concerns exist, but the dose should not be considered valid. You should administer a dose of Shingrix to the patient during that same visit (same day). If the error is not detected and corrected on the same day, Shingrix should be administered at least 8 weeks after receipt of the varicella vaccine. However, if Shingrix is inadvertently administered less than 8 weeks after the varicella vaccine, CDC experts state that the Shingrix dose does not need to be repeated if given at least 24 days after the varicella vaccine (in other words, 4 weeks minus the 4-day grace period). A second dose of Shingrix should be given 26 months after the first dose of Shingrix.
These events should be documented and procedures put in place, such as checking the vial label 3 times to be sure you are administering the product you intend, to prevent this from happening again.
If Shingrix is erroneously given to a child for prevention of varicella, the dose is invalid, but is there a waiting period before a valid dose of varicella vaccine can be given? Is it OK to give a dose of varicella vaccine as soon as the error is discovered?
There is no waiting period. The varicella vaccine dose can be given at any time after the Shingrix dose. Review your procedures to prevent this from happening again. Always check the label 3 times to ensure you are administering the product intended. Such an error also should be reported to the Vaccine Adverse Event Reporting System (VAERS) by phone 1-800-822-7967 or online at https://vaers.hhs.gov.
We inadvertently gave a 27-year-old healthcare worker Shingrix rather than varicella vaccine for work. Does this dose count?
No. The Shingrix vaccine does not count as a vaccination against primary varicella infection (chickenpox). The first varicella vaccine dose can be given at any time after the Shingrix dose. The second dose of varicella vaccine should be given 4 to 8 weeks after the first dose. You should always check the label 3 times to ensure you are administering the product intended.
While giving a dose of Shingrix the syringe came loose from the needle and part of the dose was lost. Will the patient be protected with this partial dose or does it need to be repeated?
A dose less than the full 0.5 mL dose is generally not considered valid and should generally be repeated. If the patient is still in the office the dose can be repeated immediately. If the repeat dose cannot be given on the same day CDC recommends that it should be given 4 weeks after the invalid dose. The provider does have discretion as to whether the amount of vaccine lost is negligible, to make a decision not to repeat the dose of vaccine.
My medical assistant inadvertently administered a 0.5 mL dose of the Shingrix diluent only. The dose did not contain any antigen. When can we administer a properly reconstituted dose?
The CDC zoster subject matter experts recommend that in this situation you should wait 4 weeks before giving a repeat dose.
Several doses (antigen and diluent) of Shingrix were mistakenly stored in our office freezer. One of these doses was administered to a patient. Is this dose valid and if not, when can it be repeated?
Any Shingrix, either antigen or diluent, that is exposed to freezing temperature should not be used. If a dose exposed to freezing temperature is given to a patient the dose should be considered invalid and should be repeated 4 weeks after the invalid dose.
Storage and Handling Back to top
How should Shingrix be stored?
Both lyophilized Shingrix and the adjuvant solution diluent must be stored at refrigerator temperature, between 2° and 8°C (between 36° and 46°F). Protect the vials from light. Do not freeze. Vaccine or adjuvant solution that has been frozen must be discarded. If vaccine that was frozen was administered, the dose does not count and should be repeated. The repeat dose should be administered 4 weeks after the frozen dose. After reconstitution, administer Shingrix immediately or store refrigerated between 2° and 8°C (between 36° and 46°F) and use within 6 hours. Discard reconstituted vaccine if not used within 6 hours.
How should Shingrix be transported to an off-site clinic location?
Shingrix is stored at refrigerator temperature. Transport of refrigerated vaccines is described in detail in the CDC Storage and Handling Toolkit, available at www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf, pages 2224. Providers should also review the vaccine package inserts for the specific vaccines being transported.
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This page was updated on January 31, 2023.
This page was reviewed on March 9, 2022.
 
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